纳武单抗联合易普利姆玛已证明可改善初治晚期透明细胞肾细胞癌 (RCC) 的生存率。一系列临床试验评估了挽救性纳武单抗加伊匹单抗对纳武单抗无客观反应的患者的效果。考虑到这些研究的规模和异质性，我们进行了汇总分析，以更好地了解纳武单抗加伊匹单抗治疗后纳武单抗的活性。符合条件的患者包括既往未接受过免疫治疗的晚期透明细胞肾细胞癌患者。主要目标是通过研究者评估确认客观缓解率（ORR）。次要目标包括无进展生存期 (PFS) 和总生存期 (OS)。该分析包括 410 名透明细胞肾细胞癌患者，其中 340 名 (82.9%) 患有 IMDC 中危/低危疾病，137 名 (33.4%) 既往患有 IMDC治疗。在纳武单抗加伊匹单抗之前，纳武单抗的 16-18 周 ORR 为 22.7% (n = 93)，纳武单抗的最佳 ORR 为 25.1% (n = 103)。 230 例 (56.1%) 接受纳武单抗治疗的患者在开始纳武单抗治疗后平均 16 周 (IQR 9-19) 接受纳武单抗加伊匹单抗治疗 [27.0% (n = 62) 疾病稳定，73.0% (n = 168) ）疾病进展至纳武单抗]。纳武单抗加伊匹单抗的 ORR 为 12.6% (n = 29)。纳武单抗加伊匹单抗治疗的 6 个月 PFS 为 37%（95% CI，27-47）。从纳武单抗开始起，中位随访时间为 34.3 个月，3 年 OS 为 59%（95% CI，53-64）。一小部分对纳武单抗缺乏反应的患者从挽救性纳武单抗加伊匹单抗中获益。如果可能，两种药物应同时服用，而不是以适应性方式服用。© 作者 2023。由牛津大学出版社出版。

Nivolumab plus ipilimumab has demonstrated improved survival for treatment-naïve advanced clear cell renal cell carcinoma (RCC). A series of clinical trials evaluated the effect of salvage nivolumab plus ipilimumab in patients without an objective response to nivolumab. Given the size and heterogeneity of these studies, we performed a pooled analysis to better inform the activity of nivolumab plus ipilimumab after nivolumab.Eligible patients included those with advanced clear cell RCC having received no prior immunotherapy. The primary objective was confirmed objective response rate (ORR) by investigator-assessment. Secondary objectives included progression-free survival (PFS) and overall survival (OS).The analysis included 410 patients with clear cell RCC, of whom 340 (82.9%) had IMDC intermediate/poor risk disease, and 137 (33.4%) had prior treatment. The 16-18-week ORR to nivolumab prior to nivolumab plus ipilimumab was 22.7% (n = 93), and best ORR to nivolumab was 25.1% (n = 103). Two hundred and thirty (56.1%) patients treated with nivolumab received nivolumab plus ipilimumab at a median of 16 weeks (IQR 9-19) after initiation of nivolumab [27.0% (n = 62) with stable disease and 73.0% (n = 168) with progressive disease to nivolumab]. The ORR to nivolumab plus ipilimumab was 12.6% (n = 29). Six-month PFS on nivolumab plus ipilimumab was 37% (95% CI, 27-47). Median follow-up was 34.3 months and 3-year OS was 59% (95% CI, 53-64) from nivolumab start.A small subset of patients lacking a response to nivolumab derive benefit from salvage nivolumab plus ipilimumab. When possible, both drugs should be given in concomitantly, rather in an adaptive fashion.© The Author(s) 2023. Published by Oxford University Press.